AstraZeneca Stock Price, News & Analysis

AstraZeneca (AZN) and Daiichi Sankyo announced U.S. FDA approval of ENHERTU plus pertuzumab as a first-line treatment for adult patients with unresectable or metastatic HER2 positive breast cancer, based on DESTINY-Breast09 phase 3 results.

The trial showed a 44% reduction in risk of progression or death (HR 0.56; 95% CI 0.44-0.71; p<0.0001), median PFS of 40.7 months vs 26.9 months for THP, ORR 87% vs 81%, and confirmed CR rates 15% vs 8%. Safety included Boxed WARNINGS for ILD/pneumonitis and embryo-fetal toxicity; serious adverse reactions occurred in 27% and fatalities in 3.4% of patients. A $150 million milestone from AstraZeneca to Daiichi Sankyo is payable following approval.

AstraZeneca (AZN) announced on December 9, 2025 that the first patient has been dosed in the randomized phase of the DESTINY-Ovarian01 phase 3 trial. The study is evaluating ENHERTU (trastuzumab deruxtecan) plus bevacizumab versus bevacizumab monotherapy as first-line maintenance after platinum-based chemotherapy with bevacizumab in patients with HER2 expressing (IHC 3+/2+/1+) advanced high-grade epithelial ovarian cancer.

The trial is conducted with ENGOT partners (GEICO lead), GOG-F, and APGOT. The announcement cites prior DESTINY-PanTumor02 ovarian cohort data showing clinically meaningful, durable responses in previously treated patients and notes HER2 expression in up to 55% of ovarian cancers, a 5-year survival of 31.8% for advanced disease, and 70–80% recurrence rates after standard treatment.

Salesforce (NYSE: CRM) announced on December 4, 2025 that AstraZeneca (AZN) selected Agentforce Life Sciences for Customer Engagement as its unified global platform to transform customer engagement with healthcare professionals.

The collaboration expands Agentforce 360 for Life Sciences to provide medical-commercial coordination, personalized next-best-action engagement, multi-channel campaign orchestration, and Model Context Protocol (MCP) interoperability via Salesforce’s Agent Fabric.

The companies say the platform aims to improve strategic customer outcomes, streamline field engagement, and support AstraZeneca’s work across oncology, rare diseases, cardiovascular, renal and metabolism, and respiratory and immunology.

AstraZeneca (AZN) will present its largest-ever hematology program at the 67th ASH Annual Meeting, December 6–9, 2025, with 65 abstracts across eight approved and investigational medicines and 15 oral presentations. Key highlights include a three-year follow-up Phase I study of surovatamig (CD19xCD3 T-cell engager) in relapsed/refractory follicular lymphoma, initial DURGA-1 data for AZD0120 (BCMAxCD19 CAR T) in relapsed/refractory multiple myeloma, 50-month ECHO results for CALQUENCE in first-line mantle cell lymphoma, and Phase III pediatric data for ULTOMIRIS in HSCT-associated thrombotic microangiopathy. Additional abstracts cover safety, subgroup analyses, real-world evidence, and other investigational assets.

AstraZeneca (NYSE:AZN) announced the US FDA has accepted the New Drug Application for baxdrostat under Priority Review for adults with hard-to-control hypertension, with a PDUFA target in Q2 2026. The NDA is based on the BaxHTN Phase III trial (n=796) that met primary and all secondary endpoints, showing placebo-adjusted seated systolic BP reductions of 9.8 mmHg (2 mg) and 8.7 mmHg (1 mg) at week 12. Baxdrostat was generally well tolerated and is being studied across a program of >20,000 patients for hypertension, primary aldosteronism, CKD and heart failure combinations.

Vistagen (Nasdaq: VTGN) appointed Nick Tressler as Chief Financial Officer effective December 1, 2025. Mr. Tressler has over 20 years of life‑science financial leadership, most recently serving as CFO of DYNEX Technologies and previously at American Gene Technologies and Senseonics (Nasdaq: SENS). He held senior roles at Sucampo (acquired 2018) and MedImmune (acquired 2007) and holds an MBA from Johns Hopkins.

The Compensation Committee granted an inducement incentive option for 150,000 shares with an exercise price equal to the December 1, 2025 closing price; vesting is 25% after one year, then monthly ratable vesting over 36 months.

AstraZeneca (NYSE:AZN) announced US FDA approval of IMFINZI (durvalumab) plus FLOT chemotherapy as the first and only perioperative immunotherapy for resectable early-stage and locally advanced (Stages II, III, IVA) gastric and gastroesophageal junction cancer.

Approval is based on MATTERHORN Phase III results showing a 29% reduction in risk of progression, recurrence or death (EFS HR 0.71; P<0.001) and a 22% reduction in risk of death (OS HR 0.78; P=0.021). Estimated three-year survival was 69% vs 62%. Safety was consistent with known profiles; Grade≥3 AEs were similar between arms (~71%).

AstraZeneca (AZN) will invest $2 billion to expand biologics manufacturing in Frederick, Maryland, and build a new clinical manufacturing facility in Gaithersburg, with both sites expected to be operational by 2029.

The plan nearly doubles commercial biologics capacity, onshores production for the rare disease portfolio, supports 2,600 jobs across both sites (including ~1,900 construction roles), and leverages AI, automation and high environmental standards. This is part of AstraZeneca's historic $50 billion US manufacturing and R&D commitment.

AstraZeneca (NYSE:AZN) reported positive Bax24 Phase III results on November 9, 2025: baxdrostat 2 mg produced a placebo-adjusted -14.0 mmHg reduction in 24‑hour ambulatory systolic blood pressure at 12 weeks (95% CI -17.2, -10.8; p<0.0001).

Key secondary results included a -13.9 mmHg night‑time SBP reduction and a -10.3 mmHg seated SBP reduction versus placebo; 71% of baxdrostat patients achieved ambulatory 24‑hour SBP <130 mmHg versus 17% on placebo (odds ratio 15.2; p<0.0001). Safety was reported as generally well tolerated and consistent with prior BaxHTN data. Full results were presented at AHA Scientific Sessions 2025 and will be shared with regulators.